Proactive Fecal Calprotectin Home Monitoring in Ulcerative Colitis: Results of a Prospective Randomized Control Trial.

Abstract

Elevated fecal calprotectin (FC), a biomarker of intestinal inflammation, can be detected 3 months before symptomatic flare in patients with ulcerative colitis (UC). We hypothesized that proactive home-based FC monitoring would prevent symptomatic flares in patients with UC in remission. This prospective, multicenter clinical trial randomized adults with modified partial Mayo score ≤2 and no rectal bleeding to standard care or FC testing every 2 months for 18 months or until symptomatic flare. Confirmatory FC testing was performed within 2 weeks for FC ≥250 μg/g; change in therapy was at physician discretion. Primary endpoint was time to symptomatic flare. Secondary endpoints included healthcare utilization, medication use, and quality of life. 716 patients were enrolled; 308 in the control arm and 303 in the intervention arm were analyzed. Mean age was 42 and 47% were male. Distribution of disease extent was similar in both arms and 45% were on advanced therapy. 32% in both arms had symptomatic flare; median time to flare was not reached. There was no difference in risk for symptomatic flare overall (HR 1.05 [95% CI: 0.79, 1.40]), by disease extent, or advanced therapy use. Flare frequency was lower among the 88 who changed therapy after confirmatory elevated FC (49% vs 55%) but flare risk was not different. There were no differences in secondary endpoints. Our results suggest that proactive home-based FC monitoring without protocolized escalation does not prevent symptomatic flares. Additional studies are needed to define the optimal use of FC monitoring and the benefit of early intervention; ClinicalTrials.gov number: NCT03549988.